A Study of NPX267 for Subjects With Solid Tumors Known to Express HHLA2/B7-H7

Clinicaltrials.gov ID: NCT05958199
db-list-check Status RECRUITING
b-loader Phase PHASE1
b-people Age ≥ 18 Years
b-bullseye-arrow Enrollments 131

Conditions

Metastatic Malignant Neoplasm

Drugs

NPX267

Summary

NPX267 is an antibody drug targeting the inhibitory receptor for B7-H7 (HHLA2) which may control evasion of the immune response in tumors. The goal of this clinical trial is to learn whether NPX267 is safe and tolerable in patients whose cancers are known to express HHLA2 including epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer. The main questions it aims to answer are:* what is an appropriate dose to be given to patients? * are the side effects of treatment manageable?Participants will be evaluated for participation in the study. Patients who are treated will receive an intravenous infusion of NPX267 every three weeks if their disease has not progressed. Patients will be closely monitored by the treating physician.

Detailed Description

This trial is divided into two parts. The first part (dose escalation) will test different doses of drug to find a dose for part two. In the second part (dose expansion), more patients will be tested to see if the drug has an effect on patient’s tumors.

Throughout the study, data will be collected to characterize the clinical activity of the drug. Samples of blood will be taken to help in an understanding of how the drug behaves in the body by assessing the amount of drug in the blood over time (pharmacokinetics), and changes in blood components (pharmacodynamics and safety). Tumor imaging by computed tomography (CT) or magnetic resonance imaging (MRI) will be done about every nine weeks to assess NPX267 impact on tumor growth.

Locations

7 locations Found with status Recruiting

Status

  • RECRUITING

Contact Person

Status

  • RECRUITING

Contact Person

Status

  • RECRUITING

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Status

  • RECRUITING

Contact Person

Status

  • RECRUITING

Contact Person

Status

  • RECRUITING

Contact Person

Status

  • RECRUITING

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Eligibility Criteria

Inclusion Criteria:

* Histologically or cytologically confirmed recurrent, metastatic solid tumor refractory to standard of care therapy in one of the following indications: Part 1a: non-small cell lung carcinoma (NSCLC), renal cell carcinoma (RCC), colorectal carcinoma (CRC), cholangiocarcinoma (CCA), pancreatic cancer (PDAC), urothelial carcinoma (UCC), gastric/gastroesophageal carcinoma, triple negative breast carcinoma, endometrial carcinoma, cervical cancer, osteosarcoma, and prostate cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Normal bone marrow, kidney and liver function
* Willing to use highly effective contraceptive measures throughout the trial

Exclusion Criteria:

* Have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia, chronic neuropathy > 6 months, or changes in skin pigmentation
* Have known or suspected brain metastases, unless they are clinically stable
* Known autoimmune disease requiring immunosuppressive treatment requiring the equivalent of more than 10 mg prednisone daily
* History of grade 3 immune-related pneumonitis or colitis

Study Plan

NPX267 Treatment

  • DRUG:

    NPX267

    Description:

    NPX267 will be administered by intravenous infusion every three weeks until documented disease progression or participant withdrawal

Outcome Measures

Primary Outcome Measures

Incidence of dose limiting toxicity

Time Frame: from first dose through 21 days

Incidence of treatment-emergent adverse events

Time Frame: up to 12 weeks from first dose

Number of subjects with tumor response in tumors expressing B7-H7/HHLA2

Time Frame: up to 12 weeks from first dose

Secondary Outcome Measures

Area under the concentration curve (AUC) of NPX267

Time Frame: Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)

Half-life in circulation (T1/2) of NPX267

Time Frame: Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)

Maximum plasma concentration (Cmax) of NPX267

Time Frame: Following dosing on day 1, day 22, and day 43 (day 1 of 21-day treatment cycles)

Overall survival

Time Frame: From first dose until death from any cause through 30 months

Immunogenicity of NPX267

Time Frame: From first dose through one year

Timeline

  • Last Updated
    August 28, 2024
  • Start Date
    July 24, 2023
  • Today
    February 5, 2025
  • Completion Date ( Estimated )
    January 1, 2026

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